ID

22273

Beschrijving

A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stem™ AMT in a Total Primary Hip Replacement; ODM derived from: https://clinicaltrials.gov/show/NCT00872573

Link

https://clinicaltrials.gov/show/NCT00872573

Trefwoorden

  1. 28-05-17 28-05-17 -
Geüploaded op

28 mei 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00872573

Eligibility Rheumatoid Arthritis NCT00872573

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
i) male or female subjects, aged between 60 and 80 years inclusive.
Beschrijving

gender, age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
ii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
iii) subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Beschrijving

compliance

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
iv) subjects undergoing primary total hip replacement that are considered suitable for a cemented femoral stem and metal femoral head and an all polyethylene acetabular cup.
Beschrijving

total hip replacement

Datatype

boolean

Alias
UMLS CUI [1]
C0040508
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
ii) subjects undergoing revision hip replacement
Beschrijving

revision hip replacement

Datatype

boolean

Alias
UMLS CUI [1]
C0186201
iii) subjects undergoing simultaneous bilateral hip replacements.
Beschrijving

simultaneous bilateral hip replacement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040508
UMLS CUI [1,2]
C0238767
UMLS CUI [1,3]
C0521115
iv) subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.
Beschrijving

contralateral hip replacement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040508
UMLS CUI [1,2]
C0441988
v) women who are pregnant.
Beschrijving

pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
vi) subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Beschrijving

substance abuse, psychological disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0004936
vii) subjects who have participated in a clinical study with an investigational product in the last 12 months.
Beschrijving

study participation, investigational product

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3898691
viii) subjects who are currently involved in any injury litigation claims.
Beschrijving

injury litigation claims

Datatype

boolean

Alias
UMLS CUI [1,1]
C3263723
UMLS CUI [1,2]
C0079706
UMLS CUI [1,3]
C0021677

Similar models

Eligibility Rheumatoid Arthritis NCT00872573

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
gender, age
Item
i) male or female subjects, aged between 60 and 80 years inclusive.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
informed consent
Item
ii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
boolean
C0021430 (UMLS CUI [1])
compliance
Item
iii) subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
boolean
C1321605 (UMLS CUI [1])
total hip replacement
Item
iv) subjects undergoing primary total hip replacement that are considered suitable for a cemented femoral stem and metal femoral head and an all polyethylene acetabular cup.
boolean
C0040508 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
boolean
C0009488 (UMLS CUI [1])
revision hip replacement
Item
ii) subjects undergoing revision hip replacement
boolean
C0186201 (UMLS CUI [1])
simultaneous bilateral hip replacement
Item
iii) subjects undergoing simultaneous bilateral hip replacements.
boolean
C0040508 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0521115 (UMLS CUI [1,3])
contralateral hip replacement
Item
iv) subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.
boolean
C0040508 (UMLS CUI [1,1])
C0441988 (UMLS CUI [1,2])
pregnancy
Item
v) women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
substance abuse, psychological disorders
Item
vi) subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
study participation, investigational product
Item
vii) subjects who have participated in a clinical study with an investigational product in the last 12 months.
boolean
C2348568 (UMLS CUI [1,1])
C3898691 (UMLS CUI [1,2])
injury litigation claims
Item
viii) subjects who are currently involved in any injury litigation claims.
boolean
C3263723 (UMLS CUI [1,1])
C0079706 (UMLS CUI [1,2])
C0021677 (UMLS CUI [1,3])

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